1. The VOHC awards its Seal in two claim categories – Helps Control Plaque, and Helps Control Tartar. A separate submission (and submission fee) is required for each claim. In addition, if a Product is available in more than one size or shape etc., the VOHC will require a separate submission (and fee) for each form of the Product if there is a significant difference in the Product or in the population for which the Product is marketed. For example:
   
   
   • A Product that is available in two sizes labeled for, and marketed to, medium-large dogs for one size and small dogs for the other size will require separate submissions because of the documented differences in the dental anatomical features and periodontal disease prevalence data between small and medium-large dogs.
   • A Product that is available in two slightly different shapes or sizes and is labeled for, and marketed to, the same size range of dogs will not require two separate submissions, provided that there are no changes in the consistency, flavoring or manufacturing methods etc., that may cause differences in the effectiveness of the two forms of the Product.
   
   VOHC will determine whether a separate submission is required for different sizes, etc. Please note that the Seal is awarded for use in connection with the specific Product that was tested – if a developmental Product was tested, and substantial changes were subsequently made in the shape, flavoring, manufacturing methods etc., for the Product as marketed, the submitted data may be inappropriate for consideration. Please contact the VOHC office prior to submission if you have specific questions on these issues.

2. A submission will be successful if it demonstrates that the Product meets the requirements as stated in the VOHC protocol(s). Note that in some instances the requirements are very specific - the statistical hurdle required for demonstrating efficacy, for example. In other areas, the requirements are less specific – for example, a minimum trial duration period is stated, but not a maximum; the indices to be used must measure plaque or calculus specifically, but there is no required index; there is no minimum number of animals required for each group. We recognize that there is some need for flexibility, particularly when considering studies conducted before the VOHC protocol was promulgated. Alternative but credible methods of demonstrating efficacy are permitted under the VOHC system, provided that justification is provided for methods that are not in general use.

3. Data sets from two populations of animals are required. For studies conducted after January 1, 1998, in addition to requiring that the animals enrolled in the two studies must be different, at least one of the following three items must be different to meet the "two populations" requirement:
   
   
   • location of trial;
   • dates of trials;
   • principal investigator/scorer.
   • We recommend that two or more of these items are different.

4. We strongly recommend stratification prior to randomization into test groups, and recommend that randomization by blocking on stratification of the substrate under study is based on blocks equal to the number of arms in the study. Statistical significance is to be determined using a two-tailed test rather than a one-tailed test.

5. The submission must include all original data, such that an independent statistical analysis could be run by VOHC. The data may be provided in the form of a spreadsheet or database file on disk in a standard software package format, plus printed tables summarizing the whole-mouth mean scores (+/- SD) for each group.

6. The written materials submitted are to include:
   
   
   • The protocol(s) as adopted prior to conducting the trials, including details of the randomization process between groups, indices used, pre-trial and during-trial management (diet, housing etc.), and between periods management for cross-over trials.
   • A brief description of the site(s) of the trials, personnel involved (with details of the training and experience of the scorers and identification of the statistician), dates of the trials, source and identification of individual animals, certification of animal care procedures (IACUC, AALAC etc.).
   • An affadavit signed by the senior investigator and by a representative of the sponsoring company that the information submitted is complete and correct.
   • Indication of any areas in which the submission does not meet specific VOHC requirements, with reasons why the VOHC should consider such departures from its stated requirements. This could be anything from a notation that one animal was missing one of the recommended teeth, to use of an entirely new method of scoring plaque or calculus.

7. Submit one copy of the disk with the original data and 12 copies of the written submission.

8. Include the Submission Fee, as a check made out to the "American Veterinary Dental College." If the fee is not included, the company will be invoiced for the fee before the review process will be commenced. The fees are:
   
   
   • For Products marketed to the general public, whether through specialty pet stores only or through supermarkets and other points-of-sale: $5,000.
   • For Products marketed only through veterinarians or available only by prescription: $3,000
   • The Submission Fee is not refundable if the Product is not awarded the VOHC Seal.

9. If the Council recommends awarding of the VOHC Seal, a detailed Agreement must be signed by both the Company and the VOHC before the Company is permitted to use the VOHC Seal. A copy of the Agreement may be requested from the VOHC office for review prior to submission. The VOHC Seal is awarded initially for a 3-year period; an annual maintenance fee of $1,000 for mass-market products and $500 for veterinarian-only products will be billed prior to the anniversary of the awarding of the Seal. Annual renewal will ordinarily be continued beyond the initial 3-year period if the Product has not been changed in any significant way and if the VOHC Protocols have not changed in any significant way.

10. The standard Agreement limits use of the Seal to the USA. Use of the Seal outside the USA is encouraged, subject to consideration of issues such as use of the registered certification mark and translation from English. Please contact the VOHC Office for further information.
    
    
    • The VOHC Seal will be provided to the Company as camera-ready copy. The VOHC Seal Agreement contains specific language regarding advertising, packaging, etc., for materials that use the VOHC Seal. Draft designs showing proposed uses of the VOHC Seal may be submitted to the VOHC office for review during the Product Submission Review process.

        Because of the range of possibilities in differences among products in a product line (i.e. products that use the same formulation or technology to achieve a plaque and/or calculus retardant effect), it is not possible to state a definitive VOHC policy that will apply to all products.
However, VOHC recognizes that the trials required to meet VOHC protocol requirements may be cost-prohibitive if every separate product had to meet the full two-trial VOHC requirement, and that the full two-trial VOHC requirement may not be necessary for every product in a product line.
This document describes how a company can pursue permission to use the VOHC Seal on several products in the same product line. VOHC encourages companies to contact the VOHC Director prior to commencing trials, to discuss confidentially how the general policy described below may apply to specific products.
The two main issues for VOHC are whether products in the same product line:

• have different dental effectiveness, and if so, whether they each meet the minimum VOHC standard.
• are marketed for different body-size classes of dogs. (All domestic cats are considered by VOHC to be in the same body-size class).

1. Example of a Minor Difference Among Products in a Product Line:

Difference in Flavorings, No Other Differences Between Products
        A treat product is marketed in one size, but in two or more different flavors. A company submits data from two trials that meet the VOHC protocol criteria, and the two trials are conducted using one product, as is required by VOHC. Thus there are no data presented to VOHC from trials for product coated with the other flavors. VOHC would permit the Seal to be used on the product with the other flavors if the company explained to VOHC why the difference in the flavorings would not affect the rate of dental plaque and/or calculus deposition compared with the tested product.

2. Examples of Major Differences:

2 A. Differences in Size of Product and in Body Size Classes of Dogs
        A significant difference in size of a chewed product (and thus likely chewing time) would be reason for VOHC not permitting use of the Seal on other sizes of the product, even when a product of one size has satisfactorily completed the VOHC review system. Conducting the two required trials using one size of product in one trial and another size in the second trial would not be accepted, because VOHC’s basic statistical hurdle includes conducting two trials of the same product, in both of which the product performs significantly better than the control.
        Differences in size of product are compounded by the fact that products of different sizes are often marketed to the public for use in dogs of specific body-sizes (e.g. the ‘Giant Size’ package may state ‘For Giant-sized Dogs’).
        Based on epidemiological evidence (refs. 2,3), toy and small-breed dogs are more prone to develop severe periodontal disease than are larger dogs. In addition to having smaller jaws in absolute terms, small dogs have teeth that are proportionately larger relative to jaw size than those of larger dogs (1). In the largest detailed epidemiological study in dogs (3), the body weight groups analyzed were <7 kg, 7-13kg, 13-27 kg, and > 27 kg. With increasing body weight, there was a significant decrease in gingival index, mobility index, attachment loss and presence of a complete furcation defect. The decrease was more obvious when comparing small dogs with medium-large sized dogs than when comparing medium-sized dogs with large-sized dogs.
        Based on this evidence of increased severity of disease and anatomical pre-disposition in small dogs, VOHC requires evidence of effectiveness for products marketed for small dogs and for products marketed for medium-sized and larger dogs. Given that there are insufficient data on which to define rigid body-weight groups, VOHC is willing to review body-weight grouping prior to commencing the trials, and encourages companies to contact the VOHC Director to discuss this. VOHC will take into consideration the availability of dogs of different body sizes for clinical trials. As a general guide, median group body-weight of <7 kg (<15.5lbs) in small dogs and >12kg (>26lbs) in larger dogs is required, and median and mean body weights are to be similar in the test and control groups in each body size trial.

• When two sizes of a product are marketed:
  Testing the small-sized product in small dogs using the VOHC two-trial criterion, and testing the large-sized product in large dogs in one VOHC trial (or vice-versa) will be acceptable. If results in all three trials exceed the VOHC statistical criteria, the VOHC Seal may be used for both products.
• When more than two sizes of a product are marketed:
  Testing the small-sized product in small dogs using the VOHC two-trial criterion, and testing the large-sized product in large dogs in one VOHC trial (or vice-versa) is recommended. If results in all three trials exceed the VOHC statistical criteria, other sizes of product will be permitted to use the Seal without further testing.

2 B. Differences in Shape of Product Many dog and cat treat product lines are marketed in a variety of shapes. These different shapes may have widely different abilities to retard plaque and calculus deposition, based on interest of the dog or cat in chewing the product and on the mechanical effect the treat has on the teeth. In the absence of results of testing for each shape, this is a frustrating situation for VOHC and industry. Testing of each different shape per VOHC protocol may be prohibitively expensive. The general policy outlined in item 2A, above, may be applicable. Assuming that there is prior agreement with VOHC on what constitutes the "ends of the range of shapes" and what constitutes "intermediate shapes", testing products at either end of a spectrum of shapes (using VOHC criteria as in 2A, and with results that meet VOHC statistical standards in all trials) will permit use of the Seal on those two products and on any intermediate shapes. VOHC strongly recommends pre-trial discussion between the company and VOHC with regard to what constitutes the "ends of the range of shapes" and what constitutes "intermediate shapes". The body-size(s) of the dogs for which the products are marketed is/are to be taken into consideration.

2 C. Other Differences, e.g. Nutritional Formulation
        When a line of products incorporating the same dental formulation or technology is marketed in a number of different nutritional profiles (e.g. for different life-stages, or an obesity control formula versus a maintenance formula), and the general physical characteristics of the diet such as kibble size are very similar in each product, VOHC will consider a submission to award the Seal to all of the products in that line based on: A two-trial study as per VOHC protocol using one of the products (“primary product"), and a single trial of each of the other products in the same product line for which the Seal is requested, provided that the single trial of each additional product demonstrated that each additional product is statistically “at least as good as" the product subjected to the standard two-trial protocol, and that the company provides appropriate information about the differences in the formulations. If one of the additional products was not statistically “at least as good as" the primary product, the additional product may still be eligible for the VOHC Seal if a second trial of that specific product, in combination with the first trial of that specific product, meets the VOHC criteria for an original submission.
        This policy is subject to the provision regarding body size noted in 2A above, and possibly additional considerations. For example, consider a dental diet line that includes a diet marketed for diabetic dogs and another for non-diabetic obese dogs, both of which incorporate the same dental technology as the maintenance formula diet that has been awarded the VOHC Seal. The diabetic diet may have a higher fiber content than the maintenance diet as part of its diabetic control mechanism (and thus may have potentially higher dental abrasive action), and the glucose concentration in saliva may be higher in the diabetic dogs (which may have a stimulatory effect on oral bacterial growth). The obesity diet may have a higher fiber content than the maintenance diet, as well as lower carbohydrate/fat/protein content. Separate two-trial submissions would be required for each additional diet in the absence of explanations satisfactory to VOHC that the differences in dental effectiveness are not significant. For example, clinical pathology laboratory data may show that the serum glucose concentration in the previously diabetic patients on a diabetic control diet, combined with medical management of the diabetes, may no longer be different from the control population.
        Other differences in products in a product line will be considered on request, and the VOHC decision will be based on the general policies described above.

3. Submission Fees
        Submission fees for a multi-product submission, or for a subsequent request to add another product in the same product line, will be pro-rated, based on then-current standard VOHC submission fees.

References:

1. Gioso MA et al: Mandible and mandibular first molar tooth measurements in dogs: relationship of radiographic height to body weight. J Vet Dent 18; 65-68, 2001
2. Hamp SE et al: Macroscopic and radiologic investigation of dental diseases of the dog. Vet Radiol; 25, 86-92, 1984.
3. Harvey CE et al: Association of age, and body weight with periodontal disease in North American dogs. J Vet Dent 11; 94-105, 1994.